Plug with detachable guidewire element and methods for use

ABSTRACT

An apparatus for sealing a passage through tissue includes a bioabsorbable, threaded plug carried by a delivery device. A guide wire is receivable through lumens in the plug and delivery device that includes wings on a bioabsorbable distal portion. With the wings collapsed, the guide wire is advanced through the passage into a blood vessel, the wings expanding once located within the vessel, and the guide wire is withdrawn until the wings contact the vessel wall. The plug is threaded into the passage over the guide wire until the plug is disposed adjacent the wings. The distal portion of the guide wire is secured to the plug, e.g., by compressing a collet within the plug lumen that seals the lumen, and is severed from a proximal portion thereof. Thus, the plug and distal portion are deployed with the plug sealing the passage.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation of application Ser. No. 11/101,058,filed on Apr. 6, 2005, now U.S. Pat. No. 7,753,933, which is acontinuation of application Ser. No. 10/143,514, filed on May 10, 2002,now U.S. Pat. No. 6,890,343, which is a continuation-in-part ofapplication Ser. No. 09/866,548, filed May 25, 2001, now U.S. Pat. No.6,663,655, which is a continuation-in-part of application Ser. No.09/738,431, filed Dec. 14, 2000, now U.S. Pat. No. 6,846,319, thedisclosures of which are expressly incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates generally to apparatus and methods forsealing or closing passages through tissue, and more particularly todevices for sealing punctures or other openings communicating with bodylumens, such as blood vessels, and to apparatus and methods fordelivering such devices.

BACKGROUND

Catheterization and interventional procedures, such as angioplasty orstenting, generally are performed by inserting a hollow needle through apatient's skin and any intervening tissue into the vascular system. Aguide wire may then be passed through the needle lumen into thepatient's blood vessel accessed by the needle. The needle may beremoved, and an introducer sheath may be advanced over the guide wireinto the vessel, e.g., in conjunction with or subsequent to a dilator. Acatheter or other device may then be advanced through a lumen of theintroducer sheath and over the guide wire into a position for performinga medical procedure. Thus, the introducer sheath may facilitateintroducing various devices into the vessel, while minimizing trauma tothe vessel wall and/or minimizing blood loss during a procedure.

Upon completing the procedure, the devices and introducer sheath may beremoved, leaving a puncture site in the vessel wall. External pressuremay be applied to the puncture site until clotting and wound sealingoccur. This procedure, however, may be time consuming and expensive,requiring as much as an hour of a physician's or nurse's time. It isalso uncomfortable for the patient, and requires that the patient remainimmobilized in the operating room, catheter lab, or holding area. Inaddition, a risk of hematoma exists from bleeding before hemostasisoccurs.

Various apparatus have been suggested for percutaneously sealing avascular puncture by occluding the puncture site. For example, U.S. Pat.Nos. 5,192,302 and 5,222,974, issued to Kensey et al., describe the useof a biodegradable plug that may be delivered through an introducersheath into a puncture site. When deployed, the plug may seal the vesseland provide hemostasis. Such devices, however, may be difficult toposition properly with respect to the vessel, which may be particularlysignificant since it is generally undesirable to expose the plugmaterial, e.g., collagen, within the bloodstream, where it may floatdownstream and risk causing an embolism.

Another technique has been suggested that involves percutaneouslysuturing the puncture site, such as that disclosed in U.S. Pat. No.5,304,184, issued to Hathaway et al. Percutaneous suturing devices,however, may require significant skill by the user, and may bemechanically complex and expensive to manufacture.

Staples and surgical clips have also been suggested for closing woundsor other openings in tissue. For example, U.S. Pat. Nos. 5,007,921 and5,026,390, issued to Brown, disclose staples that may be used to close awound or incision. In one embodiment, an “S”-shaped staple is disclosedthat includes barbs that may be engaged into tissue on either side ofthe wound. In another embodiment, a ring-shaped staple is disclosed thatincludes barbs that project from the ring. These staples, however, havea large cross-sectional profile and therefore may not be easy to deliverthrough a percutaneous site to close an opening in a vessel wall.

In addition, skin seals have been proposed that may be threaded into anopening in skin. For example, U.S. Pat. No. 5,645,565, issued to Rudd etal., discloses a surgical plug that may be screwed into a puncture toseal the puncture. The surgical plug includes an enlarged cap and athreaded shaft that extends from the cap. During an endoscopicprocedure, the plug may be threaded into an opening through skin untilthe cap engages the surface of the skin. The plug is intended to sealthe opening communicating with a body cavity to prevent insufflationfluid from leaking from the cavity. Such plugs, however, may only beused at the surface of the skin, and may not be introduced throughtissue, for example, to seal an opening in the wall of a blood vessel orother subcutaneous region.

Accordingly, devices for sealing punctures or other passages throughtissue, e.g., an opening into a blood vessel, would be considereduseful.

SUMMARY OF THE INVENTION

The present invention is directed to apparatus and methods for sealingor closing passages through tissue, such as punctures communicating withblood vessels or other body lumens.

In accordance with one aspect of the present invention, a device forsealing a passage through tissue is provided that includes a body orplug member including a proximal end and a distal end. The bodygenerally includes a lumen extending between the proximal and distalends, the lumen including a reduced cross-sectional region, e.g., atapered distal region. The body may include elements, e.g., a helicalthread pattern, flutes, ribs, and/or ridges, on an outer surface thereofthat extend at least partially between the proximal and distal ends.Such elements may facilitate advancing the body into a passage throughtissue and/or sealing the passage. Alternatively, the outer surface maybe substantially smooth.

A sealing member, e.g., having a generally annular shape, is slidablydisposed within the lumen of the body that includes a lumen extendingbetween proximal and distal ends thereof, and a plurality of shouldersdisposed about the lumen of the sealing member. The shoulders may bedeflectable towards one another when the sealing member is moved atleast partially into the reduced cross-sectional region, thereby atleast partially sealing the lumen of the sealing member and/or the lumenof the body.

The body and/or the sealing member may be formed from biocompatibleand/or bioabsorbable material. Preferably, both the body and the sealingmember are bioabsorbable, thereby providing a plug member that may bedelivered into a body passage to substantially seal and/or close thepassage, the plug member remaining within the passage until it isabsorbed by surrounding tissue.

In accordance with another aspect of the present invention, an apparatusis provided for sealing a passage through tissue, e.g., to deliver aplug member. The apparatus may include a plug member, such as thatdescribed above, e.g., including a body having a lumen extending betweenproximal and distal ends thereof. The lumen may include a reducedcross-sectional region, e.g., a tapered distal region. A sealing membermay be slidably disposed within the lumen of the body that iscompressible when directed into the reduced cross-sectional region forat least partially sealing the lumen of the sealing member and/or thelumen of the body. For example, the sealing member may include aplurality of shoulders disposed about a lumen of the sealing member thatare deflectable towards one another.

In addition, the apparatus may include a handle device including anelongate outer member and an elongate inner member having proximal anddistal ends defining a longitudinal axis therebetween. The distal end ofthe outer member may be detachably coupled to the proximal end of thebody. In addition or alternatively, the distal end of the inner membermay be slidable axially within the lumen of the body for at leastpartially moving the sealing member into the reduced cross-sectionalregion of the lumen in the body, thereby deflecting the shoulderstowards one another or otherwise compressing the sealing member to atleast partially seal the lumen in the body and/or the lumen in thesealing member.

Optionally, the proximal end of the body may include a proximal openingincluding a major axis and a minor axis, e.g., an elliptical opening,and the outer member may include opposing elements on its distal end.The opposing elements may be movable away from one another to define amajor axis that substantially engages the proximal opening to secure thebody to the distal end of the outer member.

To create this engagement, the inner member may include one or moreflared regions on its distal end. The inner member may be movableproximally relative to the outer member such that the one or more flaredregions slidably engage the opposing elements to move the opposingelements away from one another to engage the walls defining the proximalopening in the body. In addition, the inner member may be movabledistally relative to the outer member for disengaging the opposingelements on the outer member from the proximal end of the body. Thesealing member may be directed at least partially into the reducedcross-sectional region of the lumen in the body as the inner member ismoved distally, thereby deflecting the shoulders on the sealing membertowards one another or otherwise compressing the sealing member to atleast partially seal the lumen in the body and/or the lumen in thesealing member.

In accordance with still another aspect of the present invention, amethod is provided for sealing a passage through tissue from a patient'sskin to a body lumen. Initially, a guide wire element is provided thatextends from the patient's skin through the passage and into the bodylumen.

A plug member, e.g., a generally annular body, may be advanced into thepassage over the guide wire element, the body including a lumen throughwhich the guide wire element is inserted as the body is advanced intothe passage. The body may include a sealing member therein at leastpartially surrounding the guide wire element. The sealing member mayinclude a lumen concentric with the lumen in the body such that theguide wire element may be inserted through both lumens.

In a preferred embodiment, the body includes an external thread pattern,and the body may be advanced into the passage by rotating the body,thereby threading the body into the passage. A handle device may becoupled to the body such that the handle device may be rotated, therebythreading the body into the passage. Once a desired location is reached,the body may be deployed from the handle device.

While or before the body is deployed, the sealing member may be directedinto a reduced cross-sectional region of the lumen in the body, therebycompressing the sealing member to at least partially seal the lumen.Preferably, a plurality of shoulders on the sealing member are deflectedtowards one another as the sealing member is directed into the reducedcross-sectional region to at least partially seal the lumen. All or aportion of the guide wire element may be withdrawn from the passage,i.e., through the body and/or handle device, before compressing thesealing member into the reduced cross-sectional region. For example, inone method, the entire guide wire element may be withdrawn before thesealing member is compressed to seal the lumen. Alternatively, at leasta portion of the guide wire element may remain within the sealing memberas it compressed, as described further below.

In accordance with another aspect of the present invention, a guide wireor positioning device is provided that includes one or more wiresincluding a proximal end and one or more lateral elements on a distalend thereof. The guide wire element may include one or more visualmarkers on the proximal end thereof, the markers being located apredetermined distance from the lateral elements. Preferably, thepredetermined distance corresponds to a length of the delivery deviceand the plug member carried thereby for providing a visual indication ofthe relative location of the lateral elements and the distal end of theplug member when the visual marker is visible beyond the proximal end ofthe delivery device.

In one embodiment, the lateral elements may include one or moreexpandable wings, and preferably, at least two opposing wings, that maybe actuable from the proximal end of the guide wire element forselectively expanding and collapsing the wings. In a preferredembodiment, the guide wire element includes an elongate outer wireincluding proximal and distal ends, one or more wings or expandablepositioning elements adjacent the distal end, one or more wings orexpandable actuator elements adjacent the proximal end, and anintermediate region extending between the positioning and actuatorelements.

The guide wire element also includes an elongate inner wire includingproximal and distal ends that are fixed relative to the proximal anddistal ends of the outer wire. The intermediate region of the outer wiremay be movable axially relative to the inner wire for expanding andcollapsing the positioning and actuator elements. Preferably, thepositioning elements are collapsed when the actuator elements areexpanded. The positioning elements may be expanded by compressing theactuator elements inwardly, thereby directing the intermediate region ofthe outer wire towards the distal end, and causing the positioningelements to buckle or otherwise expand radially outwardly. Thepositioning elements may be biased to the collapsed configuration, e.g.,such that when a constraining force on the actuator elements is removed,the positioning elements may automatically return towards the collapsedconfiguration.

Alternatively, the proximal end of the inner wire may be movable axiallyrelative to the outer wire. For example, a handle may extend from theproximal end of the inner wire, such that the handle may be directedproximally to buckle or otherwise expand the positioning elements. Inaddition or alternatively, a spring element may be coupled between theinner and outer wires for biasing the positioning and actuator elementstowards one of the collapsed and expanded configurations. Preferably,the spring biases the positioning elements to collapse towards thecollapsed configuration when the handle is released.

In accordance with yet another aspect of the present invention, anapparatus is provided for sealing a passage through tissue in a bodythat includes an elongate delivery device including a lumen extendingbetween proximal and distal ends thereof, and defining a longitudinalaxis. A plug member, such as that described above, may be detachablycarried by the distal end of the delivery device that includes a lumencommunicating with the lumen of the delivery device.

The apparatus may also include a guide wire element including a proximalend receivable through the lumens in the plug member and the deliverydevice. The guide wire element may include one or more lateral elementson a distal end thereof, for example, one or more expandable wings orlegs, as described above. The guide wire element may include one or morevisual markers on the proximal end thereof that are located apredetermined distance from the lateral elements.

In one embodiment, the lateral elements may include one or moreexpandable wings, and preferably, at least two opposing wings, that maybe actuable from the proximal end of the guide wire element forselectively expanding and collapsing the wings, as described above. Inanother embodiment, the lateral elements may include legs that arebiased to extend transversely relative to a longitudinal axis of theguide wire element, but may be deflected to a collapsed configuration tofacilitate advancing the guide wire element into a passage throughtissue.

In accordance with still another aspect of the present invention, amethod is provided for sealing a passage through tissue from a patient'sskin to a body lumen. A distal end of a guide wire element may beadvanced from the patient's skin through the passage and into a bodylumen, e.g., through a percutaneous puncture communicating with a bloodvessel. One or more lateral elements on the distal end of the guide wireelement may be expanded within the body lumen, and the guide wireelement may be at least partially withdrawn from the body lumen untilthe one or more lateral elements contact a wall of the body lumen.

A proximal end of the guide wire element may be inserted into a lumen ofa plug member, and the plug member may be advanced into the passage overthe guide wire element. In a preferred embodiment, the plug member mayinclude an external thread pattern, and the plug member may be advancedby rotating the plug member, thereby threading the plug member into thepassage.

The plug member may be advanced into the passage until the plug memberis disposed adjacent to the one or more lateral elements. The plugmember may be carried on a distal end of a delivery device, and the plugmember may be released from the distal end of the delivery device afterthe plug member is advanced into the passage. For example, the guidewire element may include a marker on a proximal portion thereof that islocated a predetermined distance from the one or more lateral elements.The plug member may be released from the delivery device when the markerappears from a proximal end of the delivery device, thereby deployingthe plug member adjacent to the one or more lateral elements.Alternatively, the plug member may be released from the delivery deviceafter the plug member contacts the one or more lateral elements.

A sealing member within the lumen in the plug member may be directedinto a reduced cross-sectional region of the lumen, thereby at leastpartially sealing the lumen. Preferably, the sealing member iscompressed before or as the plug member is deployed from the deliverydevice.

At least a portion of the guide wire element may be withdrawn from thepassage, i.e., through the lumen of the plug member. For example, theone or more lateral elements may be collapsed, and the guide wireelement may be withdrawn through the lumen of the plug member andremoved entirely from the passage. Preferably, the guide wire element iswithdrawn before the sealing member is compressed to seal the lumen inthe plug member.

In accordance with another aspect of the present invention, a device forsealing a passage through tissue is provided that includes a plugmember, such as those described above, including a lumen extendingbetween proximal and distal ends thereof, and a guide wire elementincluding a proximal end receivable through the lumen in the plugmember. The guide wire element may include one or more lateral elementson a distal portion thereof, the one or more lateral elements beingdeflectable from an expanded configuration towards a collapsedconfiguration. Optionally, the guide wire element may be tubularincluding a bleed back lumen extending between the proximal and distalends.

The distal portion of the guide wire element may be severable from aproximal portion of the guide wire element. The body and at least thedistal portion of the guide wire element may be formed frombiocompatible material, and preferably from bioabsorbable material, suchthat the body and the distal portion of the guide wire element may bereleased within a passage through tissue.

In a preferred embodiment, the lateral elements include a pair ofopposing legs extending away from one another in the expandedconfiguration. More preferably, the opposing legs define a cross-sectionthat is larger than the lumen in the plug member in the expandedconfiguration.

In accordance with yet another aspect of the present invention, anapparatus is provided for sealing a passage through tissue in a bodythat includes an elongate delivery device including a lumen extendingbetween proximal and distal ends thereof, and defining a longitudinalaxis. A plug member is detachably carried by the distal end of thedelivery device that includes a lumen communicating with the lumen ofthe delivery device.

A guide wire element is also provided that includes a proximal endreceivable through the lumens in the plug member and the deliverydevice. The guide wire element includes one or more lateral elements ona distal portion thereof, the one or more lateral elements beingdeflectable from an expanded configuration towards a collapsedconfiguration, the distal portion being severable from a proximalportion of the guide wire element. Preferably, the plug member and thedistal portion of the guide wire element are formed from at leastpartially from bioabsorbable material.

The guide wire element may include a visual marker on the proximal endthereof, the marker being located a predetermined distance from the oneor more lateral elements. The predetermined distance may correspond to alength of the delivery device and the plug member carried thereby forproviding a visual indication of the relative location of the one ormore lateral elements and the distal end of the plug member when thevisual marker is visible beyond the proximal end of the delivery device.In addition or alternatively, the guide wire element may include a bleedback lumen extending between its proximal and distal ends.

In addition, the plug member may include a sealing member slidablydisposed within the lumen of the plug member. In one embodiment, thesealing member may include a plurality of shoulders disposed about alumen of the sealing member, the shoulders being deflectable towards oneanother for at least partially sealing the lumen of the sealing member.

The sealing member may be movable into a reduced cross-sectional regionof the lumen in the plug member for at least partially sealing the lumenin the plug member. The sealing member may also engage a portion of thedistal portion of the guide wire element when the sealing member ismoved into the reduced cross-sectional region of the lumen in the plugmember, thereby substantially securing the distal portion of the guidewire element to the plug member. If the guide wire element includes ableed back lumen, the sealing member may compress the guide wire elementto seal the bleed back lumen when the sealing member is compressed inthe reduced cross-sectional region.

In addition, the apparatus may include a cutting element for severingthe distal portion of the guide wire element from a proximal portionthereof.

In accordance with still another aspect of the present invention, amethod is provided for sealing a passage through tissue from a patient'sskin to a body lumen. A distal end of a guide wire element may beadvanced from the patient's skin through the passage and into the bodylumen, e.g., through a percutaneous puncture into a blood vessel. Theguide wire element may include one or more lateral elements on thedistal end of the guide wire element, which may be collapsed inwardly asthe guide wire element is advanced through tissue, e.g., to reduce theguide wire element's profile and facilitate advancement through thepassage. Optionally, the guide wire element may include a bleed backlumen that extends between its proximal and distal ends, providing avisual indicator when the distal end has entered the body lumen.

Once the distal end enters the body lumen, the lateral elements mayautomatically return to a transverse, expanded configuration. The guidewire element may be partially withdrawn from the body lumen until theone or more lateral elements contact a wall of the body lumen, therebyproviding a tactile indication that the distal end of the guide wireelement is disposed adjacent the wall of the body lumen.

A proximal end of the guide wire element may be inserted into a lumen ofa plug member, and the plug member may be advanced into the passage overthe guide wire element. In one embodiment, the plug member may includean external thread pattern, and may be advanced by rotating the plugmember, thereby threading the plug member through the passage. The plugmember may be advanced into the passage until the plug member isdisposed adjacent to the one or more lateral elements.

A distal portion of the guide wire element may be secured relative tothe plug member with the one or more lateral elements disposedsubstantially against the wall of the body lumen. For example, the plugmember may include a sealing member therein at least partiallysurrounding the guide wire element. The sealing member may be directedinto a reduced cross-sectional region of the lumen, thereby securing thedistal portion of the guide wire element to the plug member. If theguide wire element includes a bleed back lumen, the sealing member mayalso compress the guide wire element to substantially seal the bleedback lumen. In addition, the sealing member may at least partially sealthe lumen in the plug member as the sealing member is directed into thereduced cross-sectional region of the lumen.

A proximal portion of the guide wire element may be removed from thepassage, leaving the plug member to substantially seal and/or close thepassage, with the distal portion of the guide wire element secured tothe plug member. For example, a cutting element may be introduced intothe passage to cut or otherwise sever the guide wire element at alocation proximal to the plug member, whereupon the proximal portion maybe withdrawn from the passage.

Other objects and features of the present invention will become apparentfrom consideration of the following description taken in conjunctionwith the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A is a perspective view of a plug member, in accordance with thepresent invention.

FIG. 1B is an end view of the proximal end of the plug member of FIG.1A.

FIG. 1C is a cross-sectional side view of the plug member of FIG. 1A,including a collet disposed therein, in accordance with the presentinvention.

FIG. 2A is a side view of a first embodiment of the collet shown in FIG.1C.

FIGS. 2B and 2C are end views of a proximal end of the collet of FIG. 2Ain open and closed positions, respectively.

FIG. 2D is a cross-sectional side view of the collet of FIG. 2A.

FIG. 3 is a perspective view of an apparatus for delivering a plugmember, in accordance with the present invention.

FIGS. 4A-4D are cross-sectional views of the distal end of the apparatusof FIG. 3, during various stages of deploying the plug member.

FIG. 4E is a cross-sectional view of the distal end of the apparatus ofFIGS. 3 and 4B, taken along line 4E-4E.

FIGS. 5A and 5B are cross-sectional views of a guide wire element of theapparatus of FIG. 3, with expandable wings thereon in collapsed andexpanded configurations, respectively.

FIGS. 6A and 6B are side views of an alternative embodiment of a guidewire element having a spring element, in accordance with the presentinvention.

FIGS. 7A-7D are side views of a plug member and handle device beingadvanced over a guide wire element, and showing positioning markers onthe guide wire element.

FIGS. 8A-8E are cross-sectional side views of a passage communicatingwith a blood vessel, showing a method for delivering a plug member toseal the passage.

FIGS. 9A and 9B are side views of yet another embodiment of a guide wireelement, in accordance with the present invention.

FIGS. 10A-10E are cross-sectional side views of a passage communicatingwith a blood vessel, showing a method for delivering a plug member intothe passage using the guide wire element of FIGS. 9A and 9B.

FIG. 11A is a cross-sectional view of an alternative embodiment of anapparatus for delivering a plug member, in accordance with the presentinvention.

FIG. 11B is a cross-sectional view of yet another alternative embodimentof an apparatus for delivering a plug member, in accordance with thepresent invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Turning now to the drawings, FIGS. 1A, 1B, and 1C show a first preferredembodiment of a plug member 12 for sealing a passage through tissue (notshown), in accordance with the present invention. The plug member 12 isa substantially rigid body, preferably having a generally cylindricalshape, including a proximal end 20, a distal end 22, and an outersurface 30. The plug member 12 includes a lumen 24 that extends betweena proximal opening 26 and a distal opening or port 28.

The plug member 12 may be formed from a biocompatible material, e.g., aplastic, such as polyethylene or polyester. Preferably, the plug member12 is formed at least partially (and more preferably entirely) frombioabsorbable material, such as collagen, polyglycolic acids (PGA's),polyactides (PLA's), and the like, which may be at least partiallyabsorbed by the patient's body over time. Alternatively, the plug member12 may be a semi-rigid or flexible body or may have a substantiallyflexible distal tip (not shown), e.g., to facilitate substantiallyatraumatically inserting the plug member 12 into a passage.

The plug member 12 may have a substantially uniform outer cross-sectiondefined by outer surface 30 or may be tapered along its length. Inaddition, the distal end 22 may be rounded to facilitate advancing theplug member 12 into a passage through tissue. In a preferred embodiment,the plug member 12 has a length of not more than about ten millimeters(10 mm), and more preferably between about one and ten millimeters (1-10mm). The plug member 12 also preferably has a diameter of between aboutone and twenty millimeters (1-20 mm). Preferably, the length anddiameter have a ratio that is not more than about two-to-one.

The plug member 12 generally includes a helical thread pattern 18,including one or more helical threads, that extends at least partiallybetween its proximal and distal ends 20, 22. Preferably, the threadpattern 18 extends completely to the distal end 22 of the plug member12, and may be tapered at the distal end 22 to facilitate introductioninto a passage through tissue (not shown). The helical thread 18 ispreferably substantially rigid and may have a substantially squarecross-section to facilitate sealing of a passage into which the plugmember 12 is threaded. The helical thread 18 may be substantiallycontinuous, i.e., extending helically around the outer surface 30 or,alternatively, may be intermittent (not shown). Alternatively, otherfeatures may be provided on the outer surface 30 instead of or inaddition to the helical thread 30, e.g., flutes, ribs, ridges, and thelike (not shown).

In a preferred embodiment, the helical thread 18 is integrally formed onthe outer surface 30 of the plug member 12. For example, the plug member12 and thread 18 may both be formed as a unitary structure, e.g., byinjection molding. Alternatively, the threads may be cut or otherwiseformed in the outer surface 30 of the plug member 12 after the plugmember 12 is formed. In a further alternative, the thread pattern may beeliminated, thereby providing a substantially smooth outer surface (notshown).

The lumen 24 extending through the plug member 12 may include a proximalregion 21 and a tapered distal region 23, the distal region 23 taperinginwardly away from the proximal region 21 towards the distal opening 28.Thus, the distal region 23 near the proximal region 21 may define alarger cross-section lumen 24 than the distal region 23 near the distalopening 28.

The proximal region 21 of the lumen 24 may be elliptical incross-section, while the outer surface 30 of the plug member 12 may besubstantially round. Thus, the proximal region 21 of the lumen 24 mayinclude a major axis A_(l) and a minor axis a₁ (best seen in FIG. 1B).The major and minor axes A₁, a_(l) of the proximal region 21 of thelumen 24, together with corresponding axes on a handle device 14 (notshown, see, e.g., FIGS. 3-4B), may provide a locking mechanism betweenthe plug member 12 and the handle device 14, as described further below.

A collet or sealing member 60 may be disposed within the lumen 24 of theplug member 12 that may be movable axially therein, e.g., from withinthe proximal region 21 towards the distal end 22 of the plug member 12.The collet 60 may be a generally annular body including a proximal end61, a distal end 62, and a lumen 64 (best seen in FIGS. 2A-2D) extendingbetween the proximal and distal ends 60, 62. When the collet 60 isdisposed within the plug member 12, the lumen 64 of the collet 60 may bein fluid communication with the lumen 24 of the plug member 12. Also,when placed within the lumen 24 of the plug member 12, the collet 60 maybe sufficiently flexible to generally conform to the shape of the lumen24. For example, if the lumen 24 of the plug member 12 is tapered alongits length and/or has an elliptical cross-section, as shown in FIGS.1A-1C, the collet 60, when placed within lumen 24, may also becometapered along its length and/or assume an elliptical cross-section.

Alternatively, other sealing members may be provided instead of thecollet 60. For example, an annular member, e.g., a helically wound sheetof material or a solid annular body, may be provided that iscompressible (not shown). Exemplary embodiments of a sealing member thatmay be incorporated into the plug member 12 are disclosed in applicationSer. No. 09/866,548, filed May 25, 2001, incorporated by referenceherein.

Turning to FIGS. 2A-2D, a preferred embodiment of the collet 60 is shownthat includes a proximal end 61 and a distal end 62 defining a lumen 64therebetween. The collet 60 also has a proximal opening 66 and a distalopening 68 that are located at the proximal and distal ends 61, 62,respectively, and communicating with the lumen 64, respectively. Aplurality of radial slots 65 may be formed in the proximal end 61 thatare oriented inwardly towards the lumen 64, thereby defining a pluralityof flexible or semi-rigid shoulders 63 disposed circumferentially aboutthe lumen 64.

The collet 60 may be formed from a biocompatible material, e.g., aplastic, such as polyethylene or polyester. Preferably, the collet 60 isformed at least partially (and more preferably entirely) frombioabsorbable material, such as collagen, polyglycolic acids (PGA's),polyactides (PLA's), and the like, similar to the plug member 12. Inaddition or alternatively, the collet 60 may be formed from a materialthat expands when exposed to fluids, e.g., collagen and/or an expandablefoam. Exemplary materials that may be appropriate for use in the collet60 and/or the plug member 12 are disclosed in U.S. Pat. No. 6,224,630,the disclosure of which is expressly incorporated herein by reference.In addition, all or a portion of the collet 60 may be coated with atherapeutic substance, such as a thrombogenic material, e.g., along thelumen 64.

Preferably, the collet 60 is more flexible than the plug member 12,thereby enabling the collet 60 to conform substantially to the contoursof the lumen 24 of the plug member 12. The collet 60 may adopt acircular cross-section when in a relaxed state (free from externalconstraints or forces), as best seen in FIG. 2B. Once placed within thelumen 24 of the plug member 12, however, the collet 60 may conformsubstantially to the contours of the lumen 24. For example, when placedwithin a lumen 24 that is elliptical in cross-section, as shown in FIG.1B, the collet 60 may also become substantially elliptical incross-section.

As best seen in FIG. 2B, the shoulders 63 are arranged around the lumen64 and initially define an expanded or open position. In the openposition, the slots 65 space apart adjacent shoulders 63 and the inneredges 67 of the shoulders 63 define a relatively open proximal opening66. Therefore, in the open position, fluid is able to flow relativelyfreely through the proximal opening 66 and the lumen 64.

Turning to FIG. 2C, the shoulders 63 are sufficiently flexible that theymay be deflected inwardly towards one another, thereby defining a closedposition. In the closed position, the inner edges 67 move towards oneanother such that the proximal opening 66 is substantially smaller, andmay be entirely closed. In the closed position, fluid flow through theproximal opening 66 is restricted, and may be substantially completelyobstructed, compared to the open position. Thus, the collet 60 may becompressed to substantially seal the lumen 24 from fluid flowtherethrough when the collet 60 is in the closed position.

The shoulders 63 of the collet 60 may be deflected from the openposition towards the closed position by exerting an inward force on theshoulders 63. For example, with the collet 63 disposed within the plugmember 12, as shown in FIG. 1C, a distal force “F” may be applied to theproximal end 61 of the collet 60. This may cause the collet 60 to enterand move distally into the tapered region 23 of the lumen 24, therebysubjecting the shoulders 63 to an inward force that causes the shoulders63 to deflect inwardly towards the closed position (not shown in FIG.1C, see, e.g., FIG. 2C).

Turning to FIGS. 3 and 4A-4E, the plug member 12 may be incorporatedinto an apparatus 10 for sealing a passage through tissue. Generally,the apparatus 10 includes a handle or delivery device 14 for carryingthe plug member 12 and/or a guide wire element 16 for positioning theplug member 12 during delivery. The handle device 14 generally includesan tubular outer member 80 and an elongate inner member 70 slidablyreceived in the outer member 80. The components of the handle device 14may be formed from conventional biocompatible materials, e.g., plastic,such as polyethylene or polyester, and/or metal, such as stainlesssteel. The handle device 14 preferably has a cross-section that isgenerally smaller than a cross-section of the plug member 12, e.g., tominimize dilation of a passage into which the apparatus 10 is inserted.

With particular reference to FIGS. 4A-4E, the inner member 70 may besubstantially rigid, and preferably is a tubular body including a lumen74 (best seen in FIG. 4E) extending between a proximal end (not shown)and a distal end 76 of the inner member 70. As best seen in

FIGS. 4A-4C, the distal end 76 of the inner member 70 preferablyincludes one or more flared regions that extend radially outwardly. Theflared region may be a substantially continuous flared ridge 77including a ramped surface 77 a extending around a circumference of thedistal end 76 and having a cross-section that is larger than the balanceof the inner member 70. The flared ridge 77 may have an ellipticalshape, as shown in FIG. 4E, although alternatively, the flared ridge mayhave a substantially circular shape (not shown). In a furtheralternative, the distal end 76 of the inner member 70 may include aplurality of ramps (not shown) extending from an outer surface of theinner member 70, e.g., in pairs opposite one another about thecircumference of the inner member 70.

Returning to FIGS. 3 and 4A-4E, the outer member 80 may be a semi-rigidor flexible tubular body including a proximal end 81 (best seen in FIG.3), a distal end 86, and a lumen 84 extending between the proximal anddistal ends 80, 86. As shown in FIGS. 4A-4C, the outer member 80 mayalso include a plurality of slots 88 that extend proximally from thedistal end 86 a relatively short distance (compared to a length of theouter member 80). Preferably, as best seen in FIG. 4E, a pair ofopposing slots 88 are provided that divide the distal end 86 intoopposing halves 89. The slots 88 enable the opposing halves 89 to expandor otherwise move away from one another to increase the cross-section ofthe distal end 86, as explained further below.

Turning to FIG. 3, a handle 42 is attached to or otherwise extends fromthe proximal end 81 of the outer member 80. An actuator, e.g., button43, extends into the handle 42 that is coupled to the proximal end ofthe inner member 70 (not shown in FIG. 3) slidably received in the outermember 80. Axial movement of the inner member 70 relative to the outermember 80 may be limited, e.g., by the button 42 and/or the flared ridge77.

For example, as shown in FIG. 4B, the inner member 70 may be positionedin a first or proximal position such that the flared ridge 77 isdisposed at least partially within the distal end 86 of the outer member80, causing the opposing halves 89 to be expanded outwardly away fromone another, and thereby increasing a major axis dimension B₁ of theouter member 80 (shown in FIG. 4E). By depressing the button 43, theinner member 70 may be directed distally relative to the outer member80, e.g., to advance the flared ridge 77 out of the distal end 86 of theouter member 80, as shown in FIG. 4C. The distal end 86 of the outermember 80 may simply be relaxed when the flared ridge 77 is removed ormay be sufficiently resilient that the opposing halves 89 return atleast partially towards one another.

This expansion of the distal end of the outer member 80 may be used tosubstantially secure the plug member 12 to the handle device 14. Turningto FIG. 4A, with the flared ridge 77 outside the distal end 86 of theouter member 80, the distal end 81 of the outer member 80 may beinserted into the proximal end 20 of the plug member 12. If the plugmember 12 includes a lumen 24 with an elliptical shaped proximal region,the slots 88 on the outer member 80 are preferably aligned with theminor axis a_(l) of the proximal region 21, as best seen in FIG. 4E. Theinner member 70 may then be directed proximally such that the rampedsurface 77 a of the flared ridge 77 slidably engages and, consequently,expands the opposing halves 89 of the outer member 80 into engagementwith the plug member 12. The major axis B₁ of the outer member 80 mayincrease substantially to the major axis A_(l) of the proximal region 21of the lumen 24, i.e., until the opposing halves 89 frictionally engagethe plug member 12. Preferably, this frictional engagement issufficiently strong that the plug member 12 is substantially fixedrelative to the outer member 80. Consequently, any rotational forceapplied to the outer member 80, e.g., to the handle 42, may betranslated to the plug member 12 without allowing the plug member 12 toslip substantially relative to the outer member 80.

During delivery of the plug member 12 to close a passage through tissue,as explained further below, the handle device 14 may be used to deploythe plug member 12 from the outer member 80 and/or to compress thecollet 60 within the plug member 12 to substantially seal the lumen 24through the plug member 12. For example, the button 43 may be depressedpartially to advance the flared ridge 77 substantially out of the distalend 86 of the outer member 80 (as shown in FIG. 4A), thereby relaxingthe opposing halves 89 and substantially reducing the frictional forcesecuring the plug member 12 to the outer member 80. Depressing thebutton 43 may also direct the distal end 76 of the inner member 70 intocontact with the proximal end 61 of the collet 60 within the lumen 24 inthe plug member 12 and cause the collet 60 to move distally within thelumen 24. Preferably, this causes the collet 60 to travel distally atleast partially into or along the tapered distal region 23 of the lumen24 (as shown in FIG. 4C), thereby compressing the shoulders 63 towardsone another to close the opening 66 therein, as explained above. Oncethe collet 60 is forced into the distal region 23 of the lumen 24,continued depression of the button 43 may cause the entire plug member12 to be directed distally relative to the distal end 86 of the outermember 80, e.g., to deploy the plug member 12 from the handle device 14.

Turning to FIGS. 11A and 11B, alternative embodiments of an apparatus110, 210 are shown that include a handle device 114, 214 that may beused to deliver a plug member 112, 212, which are similar to theembodiment described above. Generally, as shown in FIG. 11A, the handledevice 114 includes a lumen 184 that extends between its proximal end(not shown) and its distal end 186, similar to the previous embodiment.Unlike the previous embodiment, the handle device 114 and the plugmember 112 include mating threads 123, 121. Preferably, the matingthreads 123, 121 extend in the same direction as the thread pattern 118on the plug member 112. Thus, the handle device 114 may be rotated in afirst direction to thread the plug member 112 through tissue, and in asecond direction to unthread the plug member 112 from the handle device114.

Turning to FIG. 11B, in a further alternative, the plug member 212 andhandle device 214 may include cooperating connectors for releasablycoupling the plug member 212 to the distal end 286 of the handle device214. For example, the handle device 214 may include tabs 223 that may bereceived in pockets 224 in the plug member 212. Thus, as the handledevice 214 is directed distally, the plug member 212 may remain securedto the distal end 286. If the handle device 214 is directed proximally,the tabs 223 may be withdrawn from the pockets 224, thereby releasingthe plug member 212 from the handle device 214. Other exemplarycooperating connectors that may be incorporated into the apparatus 210are described in application Ser. No. 09/738,431, filed Dec. 14, 2000,which is expressly incorporated by reference herein.

Turning to FIGS. 5A and 5B, the guide wire element 16 is generally aflexible or semi-rigid elongate member including one or more expandableelements thereon. The guide wire element 16 generally includes a tubularouter element or wire 44 and an elongate inner element or wire 54 thatare at least partially slidable relative to one another. The outer wire44 may be formed from a flexible or semi-rigid material, such asplastic, and generally includes a proximal end 45 and a distal end 46,e.g., having a “J” tip or other substantially atraumatic tip. The outerwire 44 includes a proximal actuator region 47 and a distal expandableregion 48 that are coupled to one another such that as one is radiallyexpanded, the other is radially compressed, as explained further below.

For example, as shown in FIG. 5A, in a first or collapsed configuration,the distal region 48 includes one or more wings 50 that are collapsed,e.g., extending substantially parallel to the longitudinal axis 17 ofthe guidewire element 16. Thus, the outer wire 44 may have asubstantially uniform cross-section distal to the actuator region 47.Preferably, the outer wire 44 defines an outer diameter that is not morethan about half to two millimeters (0.5-2.0 mm).

The wings 50 may be formed in the outer wire 44 by creating a pluralityof longitudinal slots 51 in the wall of the outer wire 44. Living hingesor other bends 52 may be formed in the outer wire 44, e.g., by notchingthe wall or otherwise programming bends into the wall material, as isknown in the art. Similar wings 53 may be formed in the actuator region47 that, in the collapsed configuration, may extend radially outwardly.

Turning to FIGS. 3 and 5B, in a second or expanded configuration, thewings 50 on the distal region 48 extend radially outwardly and the wings53 on the actuator region 47 are collapsed, e.g., extendingsubstantially parallel to the longitudinal axis 17. In a preferredembodiment, the distal region 48 includes two opposing wings 50, as bestseen in FIG. 3, although alternatively, the distal region 48 may includefour or more wings (not shown). Similarly, the actuator region 47 mayinclude any number of wings, such as the two wings 53 shown in FIG. 5A.

Referring again to FIGS. 5A and 5B, the inner wire 54 may be solid orhollow, and may be formed from conventional guide wire materials, suchas stainless steel or Nitinol, such that the guide wire element 16 hassufficient column strength to resist buckling or kinking. The inner wire54 includes a proximal portion 55 and a distal portion 56, both of whichmay be at least partially received within the outer wire 44. With theproximal portion 55 of the inner wire 54 disposed proximal to theactuator region 47, the proximal portion 55 may be fixed relative to theouter wire 44. For example, the proximal portion 52 of the inner wire 54may be bonded to the inner wall of the outer wire 44, e.g., using anadhesive, sonic welding, melting, and the like. Similarly, the distalportion 56 of the inner wire 54 may be disposed distal to the distalregion 48 of the outer wire 44 and fixed, e.g., to the inner wall of theouter wire 44.

Thus, an intermediate region 57 of the outer wire 44 may be freelyslidable relative to an intermediate region 58 of the inner wire 54,while the respective proximal and distal ends remain fixed. Thisrelative fixation may facilitate directing the outer wire 44 between thecollapsed and expanded configurations. For example, as shown in FIG. 5A,the wings 53 on the actuator region 47 are expanded, while the wings 50on the distal region 48 are collapsed. By compressing the wings 53 onthe actuator region 47 inwardly, the intermediate region 57 of the outerwire 44 may be directed distally relative to the intermediate region 58of the inner wire 54. This causes the wings 53 on the distal region 48to buckle and expand until, when the wings 50 are collapsed, the wings53 are expanded, as shown in FIG. 5B.

In one embodiment, the outer wire 44 may be biased towards the collapsedconfiguration. Thus, when an inwardly compressive force is removed fromthe wings 53 on the actuator region 47, the wings 53 may automaticallyexpand, thereby causing the wings 53 on the distal region 48 tocollapse. Alternatively, the intermediate region 57 of the outer wire 44may be manually directed proximally, thereby collapsing the wings 50 andexpanding the wings 53.

In a further alternative, shown in FIGS. 6A and 6B, guide wire element16′ may include a spring element 144 for biasing the guide wire element16′ towards one of the collapsed and expanded configurations. The guidewire element 16′ shares common elements with guide wire element 16, andtherefore, for simplicity, the same reference numbers have been used toidentify common elements. For example, similar to the previousembodiment, the guide wire element 16′ includes outer and inner wires44, 54, the outer wire 44 including proximal and distal regions 47, 48with wings 53, 50. Unlike the previous embodiment, the proximal portion55 of the inner wire 54 is not fixed relative to the proximal end 45 ofthe outer wire 44, but is movable axially, preferably within apredetermined range.

The spring element 144 is coupled between the proximal portion 55 of theinner wire 54 and the proximal end 45 of the outer wire 44, e.g., tobias the outer wire 44 towards the collapsed configuration. Preferably,the spring element is an extension spring that is disposedconcentrically around the inner wire 54, thereby minimizing a profile ofthe guide wire element 16′. A handle 140 may be coupled to the proximalportion 55 of the inner wire 54 that extends proximally from theproximal end 45 of the outer wire 44. Thus, the handle 140 may be pulledproximally against the bias of the spring element 144, thereby directingthe inner wire 54 proximally relative to the outer wire 44 and causingthe wings 50 on the distal region 48 to expand towards the expandedconfiguration shown in FIG. 6B. When the handle 140 is released, thespring element 144 may retract the inner wire 54 distally, therebycollapsing the wings 50.

Optionally, cooperating elements or detents may be provided on thehandle 140 and/or inner wire 54, and on the outer wire 44 for limitingmovement of the inner wire 54. For example, once the handle 140 has beenpulled to expand the wings 50 on the distal region 48 of the outer wire44, the handle 140 may be rotated about the longitudinal axis 17 toengage detents (not shown) on the handle 140 and the outer wire 44 tolock the guide wire element 16′ in the expanded configuration. The guidewire element 16′ may then be manipulated, for example, to position aplug member (not shown) within a passage through tissue (also notshown), as explained below. When it is desired to collapse the wings 50,the handle 140 may be pulled proximally and/or rotated back to disengagethe detents, and then released, whereupon the spring element 144 mayautomatically cause the wings 50 to collapse to the collapsedconfiguration.

In still a further alternative, an actuator housing (not shown) may bedisposed around or otherwise coupled to the guide wire element 16 formanipulating the wings 50 on the outer wire 44 between the collapsed andexpanded configurations. For example, the actuator may include elements(not shown) that engage the proximal end 45 and intermediate portion 57of the outer wire 44. The elements may direct the intermediate portion57 axially, i.e., distally and/or proximally, relative to the proximalend 45 for expanding and/or collapsing the wings 50. In yet anotheralternative, a tubular sleeve (not shown) may be slidable over the guidewire element 16 to secure the wings 53 on the actuator region 47 whenthe outer wire 44 is in the expanded configuration.

Turning to FIGS. 7A-7D, the guide wire element 16 of FIGS. 5A and 5B (oralternatively, the guide wire element 16′ of FIGS. 6A and 6B) mayinclude one or more visual indicators that facilitate positioning ahandle device 14 and plug member 12 along the guide wire element 16during delivery. For example, the outer wire 44 may include one or morecontrasting color areas located at predetermined distances from thedistal region 48. As best seen in FIG. 7A, the outer wire 44 may includea proximal color area 59 a, a narrow color band 59 b, an intermediatecolor area 59 c, and a distal color area 59 d.

The color areas 59 a-59 d may include any color that is suitable forcasual observation by a user, with adjacent areas being differentcolors. For example, in one embodiment, the proximal color area 59 a andthe intermediate color area 59 c may be white, while the narrow colorband 59 b and the distal color area 59 d may be blue.

In addition or alternatively, the guide wire element 16 may include ableed back lumen (not shown). For example, a lumen may be providedwithin the inner wire 54 that extends between its proximal and distalends. In a further alternative, a bleed back lumen (not shown) may beprovided that extends through the plug member and/or handle device.

Turning to FIGS. 7B-7D, the handle device 14 with the plug member 12carried thereby may be advanced over the guide wire element 16, e.g.,during delivery of the plug member 12. For example, the handle device 14may be advanced after the wings 50 have been expanded to the expandedconfiguration. As the handle device 14 is initially advanced over theguide wire element 16, the proximal color area 59 a becomes visiblebeyond the handle 42 of the handle device 14, as shown in FIG. 7B.

As the handle device 14 is advanced further, the narrow color band 59 bmay becomes visible, thereby providing a warning that the plug member 12is approaching the wings 50 on the distal region 48 of the outer wire44, as shown in FIG. 7C. The narrow color band 59 b may be only a fewmillimeters long, and the intermediate color band 59 c may have apredetermined length, e.g., ten millimeters (10 mm). Finally, as shownin FIG. 7D, as the handle device 14 is advanced still further, thedistal color area 59 d may appear. The intermediate color area 59 c maybe located a predetermined distance from the wings 50 on the outer wire44. Preferably, the predetermined distance corresponds to a length ofthe handle device 14 and plug member 12 such that when the distal colorarea 59 a begins to appear, it indicates that the distal end 22 of theplug member 12 is in close proximity to the wings 50.

Turning to FIGS. 8A-8E, an apparatus 10 in accordance with the presentinvention may be used to close and/or seal a passage through tissue, forexample, a puncture 92 extending from a patient's skin 94 throughintervening tissue 96 to a blood vessel 90. Preferably, the apparatus 10is used to deliver a plug member 12 through the passage 92 to a locationin or adjacent to a wall 98 of the vessel 90 or other body lumen. Thepassage 92 may be a conventional percutaneous puncture created to accessa peripheral vessel, for example, a femoral, carotid, or radial artery.

An introducer (not shown) may be positioned through the passage 92 intothe vessel 90 in order to permit one or more instruments, e.g., guidewires, catheters, and the like (also not shown), to be advanced into thevessel 90 in order to perform a diagnostic and/or therapeutic procedureat a location within the patient's body accessible from the vessel 90.Upon completing the procedure, any instruments may be removed from theintroducer, and the introducer itself may be removed from the passage90.

Turning to FIG. 8A, with the outer wire 44 in the collapsedconfiguration, the guide wire element 16 may be introduced through thepassage 92 until the distal region 48 is located within the vessel 90,e.g., after the introducer (not shown) has been removed from the passage92. Alternatively, the introducer may remain in the passage 92, and theguide wire element 16 may be advanced through the introducer into thevessel 90, whereupon the introducer may be removed. If the guide wireelement 16 includes a bleed back lumen (not shown), as the distal region48 enters the vessel 90, blood may flow through the bleed back lumen andout the proximal end of the guide wire element 16 (not shown), therebyproviding a visual indication that the vessel 90 has been reached.

Turning to FIG. 8B, once the distal region 48 of the guide wire element16 is positioned within the vessel 90, the wings 50 may be expanded tothe expanded configuration. For example, as explained above, the wings53 on the actuator region 47 of the guide wire element 16 may becompressed inwardly, thereby expanding the wings 50 on the distal region48. Alternatively, a handle (not shown) on the guide wire element 16 maybe pulled to expand the wings 50, also as explained above. The guidewire element 16 may then be manipulated, e.g., pulled proximally, untilthe wings 50 on the distal region 48 contact the wall 98 of the vessel90, as shown in FIG. 8C, thereby providing a tactile indication of thelocation of the vessel 90.

The handle device 14 with the plug member 12 carried thereby may then beadvanced over the guide wire element 16 and into the passage 92. If theplug member 12 includes an external thread pattern 18, the handle device14 may be rotated to thread the plug member 12 through the passage 92towards the vessel 90. Alternatively, if the plug member 12 includes asubstantially smooth outer surface, it may be advanced axially throughthe passage 92 without requiring rotation of the handle member 14. Withadditional reference to FIG. 4B, it will be appreciated that, as thehandle device 14 is advanced over the guide wire element 16, the guidewire element 16 may pass through the lumen 24 of the plug member 12, andconsequently, through the lumen 64 of the collet 61 located within theplug member 12.

As explained above with reference to FIGS. 7A-7D, the guide wire element16 may include one or more visual indicators (not shown) located apredetermined distance from the wings 50. When the visual indicatorsappear from the handle device 14, they indicate that the plug member 12is located at a predetermined location relative to the wall 98 of thevessel 90. Preferably, when the visual indicators appear, the plugmember 12 is located within or adjacent the wall 98 of the vessel 90, asshown in FIG. 8C.

Thus, the guide wire element 16 and the visual indicators thereon mayidentify the location of the vessel 90 relative to the patient's skin94, and thereby indicate the depth to which the plug member 12 should beadvanced before being deployed from the handle device 14. Alternatively,if no visual indicators are provided, the wings 50 on the guide wireelement 16 may provide a tactile indication when the plug member 12 hasreached a delivery location, e.g., when the distal end 22 of the plugmember 12 contacts the wings 50 on the guide wire element 16. In afurther alternative, the plug member 12 and/or handle device 14 mayinclude one or more bleed back lumens for indicating when the plugmember 12 has entered the vessel 90, in addition to or instead of thewings 50. Additional information on methods for delivering a plug member12 using bleed back indicators may be found in application Ser. No.09/866,548, filed May 25, 2001, incorporated by reference herein.

Turning to FIG. 8D, the wings 50 on the guide wire element 16 may becollapsed back to the collapsed configuration, e.g., by releasing thewings 53 on the actuator region 47 (not shown, see FIGS. 5A and 5B) orthe handle 140 (also not shown, see FIGS. 6A and 6B). Once the wings 50are collapsed, the guide wire element 16 may be withdrawn from thevessel 90.

Turning to FIG. 8E, the plug member 12 may be deployed from the handledevice 14, and the handle device 14 withdrawn from the passage 92. Asexplained above with respect to FIGS. 4A-4D, the handle device 14 mayinclude inner and outer members 80, 70 that may be used to secure theplug member 12 to the handle device 14. When it is desired to deploy theplug member 12, the inner member 80 may be advanced distally relative tothe outer member 70. This action may also compress the collet 60 locatedwithin the plug member 12, thereby substantially sealing the lumen 24through the plug member 12. Finally, further advancement of the innermember 80 may advance the plug member off of the outer member 70,thereby releasing the plug member from the handle device 14.

Turning to FIGS. 9A and 9B, another embodiment of a guide wire element116 is shown that may be used with an apparatus to deliver a plug member12 (not shown), in accordance with the present invention. The guide wireelement 116 generally includes an elongated flexible or semi-rigid bodydefining a longitudinal axis 117 extending between a proximal end 118and a distal end 120 thereof. Optionally, the guide wire element 116 maybe tubular, e.g., including a bleed back lumen (not extending) extendingbetween the proximal and distal ends 118, 120.

The guide wire element 116 may be formed from a biocompatible material,and preferably is formed at least partially from a bioabsorbablematerial, similar to the plug member 12 described above. Morepreferably, the guide wire element 116 includes a bioabsorbable distalportion 122 that may be detached from the remainder of the guide wireelement 116. For example, the distal portion 122 may be severable fromthe remainder of the guide wire element 116. Alternatively, the guidewire element 116 may include cooperating connectors (not shown) that maybe decoupled to release the distal portion 122.

The distal end 120 of the guide wire element 116 includes one or morelateral elements 124 that are biased to extend laterally, and preferablysubstantially perpendicular, with respect to the longitudinal axis 117,as shown in FIG. 9A. In the preferred embodiment shown, the lateralelements 124 are opposing legs or wings that extend away from oneanother. Alternatively, any number, e.g., one or more, of such legs orwings may be provided. The lateral elements 124 may be deflected to acollapsed configuration, as shown in FIG. 9B, e.g., to reduce a profileof the guide wire element 116 as it is advanced through a passagethrough tissue (not shown).

Turning to FIGS. 10A-10E, a method for using the guide wire element 116to facilitate delivering a plug member 12 is shown. Similar to themethods described above, a passage 92 may be formed during a procedurethat extends through tissue 96, e.g., from a patient's skin 94 to ablood vessel 90. Before or after removing an introducer (not shown)positioned through the passage 92, the guide wire element 116 may beadvanced through the passage 92 until the distal end 120 is positionedin the vessel 90. Because the lateral elements 124 are collapsible, asthe guide wire element 116 is advanced within the passage 92, thelateral elements 124 may be deflected towards the collapsedconfiguration, as shown in FIG. 10A. If the guide wire element 116includes a bleed back lumen, as the distal end 120 enters the vessel 90,blood may flow through the bleed back lumen, providing a visualindication that the vessel 90 has been reached.

Turning to FIG. 10B, once the distal end 120 of the guide wire element116 enters the vessel 90, the lateral elements 124 may resume theirexpanded configuration. The guide wire element 116 may then be withdrawnproximally until the lateral elements 124 contact a wall 98 of thevessel 90, thereby providing a tactile indication of the location of thevessel 90 relative to the patient's skin 94.

As shown in FIG. 10C, a handle device 14 carrying a plug member 12 maybe advanced through the passage 92 over the guide wire element 116,similar to the previous embodiments. Optionally, the guide wire element116 may include visual indicators, similar to the previous embodiments,to facilitate positioning of the plug member 12 relative to the wall 98of the vessel 90. Optionally, similar to the previous embodiments, theplug member 12 and/or handle device 14 may include a bleed back lumen(not shown) for identifying when the plug member 12 has entered thevessel 90.

Once the plug member 12 is positioned at a desired location, the plugmember 12 may be deployed from the handle device 14, similar to theprevious embodiments. Unlike the previous embodiments, however, thedistal portion 122 of the guide wire element 116 may remain within thelumen 24 of the plug member 12 as the plug member 12 is deployed. If theplug member 12 includes a collet or other sealing member 60, similar tothat shown in FIGS. 4A-4D, the collet 60 may be compressed as the plugmember 12 is deployed. Thus, as the collet 60 is compressed tosubstantially seal the lumen 24, it may engage the distal portion 122 ofthe guide wire element 116, thereby substantially anchoring the distalportion 122 of the guide wire element 116 to the plug member 12. Inaddition, if the guide wire element 116 includes a bleed back lumen, thecollet 60 may compress the guide wire element 116 to substantially sealthe bleed back lumen.

In addition, or alternatively, the plug member 12 may include flanges orother locking elements (not shown) that may slidably engage the guidewire element 116 as the plug member 12 is advanced over the guide wireelement 116. If the plug member is directed proximally, the lockingelements may engage the guide wire element 116 and prevent relativemovement of the plug member 12 and guide wire element 116. Optionally,the guide wire element 116 may include ratchet elements (not shown) thatmay allow the locking elements to over the ratchet elements in a distaldirection, but interlock to prevent movement in a proximal direction.

Turning to FIG. 10D, after the plug member 12 is released from thehandle device 14, the handle device 14 may be withdrawn from the passage92, leaving the plug member 12 and the guide wire element 116 within thebody. Because the distal portion 122 of the guide wire element 116 ispreferably formed from a bioabsorbable material, the distal portion 122may be separated from the remainder of the guide wire element. Forexample, a cutting device (not shown) may be advanced into the passage92 to sever the distal portion 122, whereupon the remainder of the guidewire element 116 may be withdrawn from the passage 92. Alternatively, ifthe guide wire element 116 includes cooperating connectors (not shown),the connectors may be decoupled to release the distal portion 122.

Thus, the plug member 12, as well as the distal portion 122 of the guidewire element 116 may remain within the passage 92. The plug member 12may substantially seal and/or close the passage 92, as seen in FIG. 10E,and secure the distal portion 122 of the guide wire element 116 fromseparating from the plug member 12. As the tissue 96 surrounding thepassage 92 heals, the distal end 318 of the guide wire element 316and/or the plug member 12 may be absorbed by the body.

While the invention is susceptible to various modifications, andalternative forms, specific examples thereof have been shown in thedrawings and are herein described in detail. It should be understood,however, that the invention is not to be limited to the particular formsor methods disclosed, but to the contrary, the invention is to cover allmodifications, equivalents and alternatives falling within the spiritand scope of the appended claims.

1. An apparatus for sealing a passage through tissue in a body,comprising: an elongate delivery device comprising a lumen extendingbetween proximal and distal ends thereof; a plug member detachablycarried by the distal end of the delivery device and comprising a lumencommunicating with the lumen of the delivery device, wherein the plugmember is configured to be inserted through the tissue; and a guide wireelement comprising a proximal end receivable through the lumens in theplug member and the delivery device, the guide wire element comprising aplurality of lateral elements on a distal portion thereof, the pluralityof lateral elements having an expanded position and a collapsed positionsubstantially parallel to the delivery device; a visual indicator on aproximal portion of the guide wire element for indicating the positionof the plug member relative to plurality of lateral elements in theexpanded position.
 2. The apparatus of claim 1, wherein the visualindicator includes a marking on the guide wire element.
 3. The apparatusof claim 1, wherein the visual indicator indicates when the plug memberis adjacent to the plurality of lateral elements.
 4. The apparatus ofclaim 1, wherein the visual indicator includes colored markings on theguide wire element.
 5. The apparatus of claim 1, wherein the visualindicator includes a first marking on the guide wire element indicatingthe plug member is over the distal portion of the guide wire adjacent tothe plurality of lateral elements.
 6. The apparatus of claim 1, whereinthe visual indicator includes a second marking on the guide wire elementindicating the plug member is over an intermediate portion of the guidewire.
 7. The apparatus of claim 1 wherein the guide wire elementcomprises a bleed back lumen therein extending proximally from thedistal end, the bleed back lumen providing a visual indication that thedistal end of the guide wire has been advanced into the body lumen. 8.The apparatus of claim 1 wherein the plurality of lateral elementscomprises at least two opposing legs extending away from one another inthe expanded confirmation.
 9. The apparatus of claim 1 wherein the plugmember comprises a bioabsorbable material.
 10. The apparatus of claim 1wherein the plug member comprises threads on an exterior surface of theplug member.
 11. The apparatus of claim 1 wherein the plug membercomprises a collet within the lumen of the plug member.
 12. Theapparatus of claim 11 wherein the collet has a conical outer surface andthe lumen of the plug member has a tapered inner surface.
 13. A methodfor sealing a passage through tissue from a patient's skin to a bodylumen, comprising: advancing a distal end of a guide wire element fromthe patient's skin through the passage and into the body lumen, theguide wire element comprising one or more lateral elements on the distalend of the guide wire element and also comprising a distal portionseparately coupled to a proximal region; partially withdrawing the guidewire element from the body lumen until the one or more lateral elementscontacts a wall of the body lumen; advancing a plug member detachablycarried by the distal end of the delivery device into the passage whilethe guide wire element is within a plug member lumen and a deliverydevice lumen until a visual indicator on a proximal portion of the guidewire element indicates that the plug member is adjacent to the one ormore lateral elements; and decoupling and removing a proximal portion ofthe guide wire element from the passage.
 14. The method of claim 13,wherein the visual indicator indicates that the plug member is adjacentto the one or more lateral elements by exposing a marking on the guidewire element.
 15. The method of claim 13, wherein the visual indicatorincludes colored markings on the guide wire element and the advancing ofthe plug member is stopped when the colored marking is exposed from thelumen of the delivery device .
 16. The method of claim 13 wherein theguide wire element comprises a bleed back lumen therein extendingproximally from the distal end and the advancing of the distal end ofthe guide wire element is stopped after the bleed back lumen providing avisual indication that the distal end of the guide wire has beenadvanced into the body lumen.
 17. The method of claim 13 furthercomprising: extending at least two opposing legs away from one anotherto expand the lateral elements after advancing the distal end of theguide wire element into the body lumen.
 18. The method of claim 13wherein the plug member comprises a bioabsorbable material and the plugmember is absorbed by the passage under the patient's skin after thedecoupling and removing the proximal portion of the guide wire elementfrom the passage.
 19. The method of claim 13 wherein the plug membercomprises a collet within the lumen of the plug member and the colletseals the lumen after the decoupling and removing the proximal portionof the guide wire element from the passage.